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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-007485-38 | EudraCT Number | EudraCT |
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Efficacy of BI 1356 compared to placebo in patients for whom metformin therapy is inappropriate (intolerability, contraindication). The second part of the study looks at the safety of BI 1356 in this patient population with longer term treatment in comparison to a sulfonylurea drug (glimepiride)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Linagliptin | Experimental | 52 week treatment |
|
| Placebo | Placebo Comparator | First 18 weeks of treatment |
|
| Glimepiride | Active Comparator | Placebo patients switch to glimepiride week19-52 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Linagliptin | Drug | 5mg once daily |
| |
| Linagliptin Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c Change From Baseline at Week 18 (Interim Analysis) | HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance. | Baseline and week 18 |
| HbA1c Change From Baseline at Week 18 (Final Analysis) | HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance. HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance. The primary analysis was re-run at the completion of the study in the final study report. | Baseline and week 18 |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting Plasma Glucose (FPG) Change From Baseline at Week 18 (Interim Analysis) | This change from baseline reflects the Week 18 FPG minus the Week 0 FPG. Means are adjusted for baseline FPG, baseline HbA1c, prior OADs and reason for metformin intolerance (Interim Analysis). | Baseline and week 18 |
| Percentage of Patients With HbA1c<7.0 at Week 18 (Interim Analysis) |
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Inclusion criteria Patients between 18 and 80 years old with type 2 diabetes and insufficient glycemic control (HbA1c 7% to 10%) for whom metformin therapy is inappropriate (intolerability or contraindication)
Exclusion criteria Myocardial infarction, stroke or Transient ischaemic attack in last 6 months Treatment with rosiglitazone or pioglitazone, GLP-1 analogues, insulin or anti-obesity drugs in past 3 months Impaired hepatic function Severe renal impairment current treatment with systemic steroids change in dosage of thyroid hormones hereditary galactose intolerance
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1218.50.10009 Boehringer Ingelheim Investigational Site | Birmingham | Alabama | United States | |||
| 1218.50.10011 Boehringer Ingelheim Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22974280 | Derived | Barnett AH, Patel S, Harper R, Toorawa R, Thiemann S, von Eynatten M, Woerle HJ. Linagliptin monotherapy in type 2 diabetes patients for whom metformin is inappropriate: an 18-week randomized, double-blind, placebo-controlled phase III trial with a 34-week active-controlled extension. Diabetes Obes Metab. 2012 Dec;14(12):1145-54. doi: 10.1111/dom.12011. Epub 2012 Oct 1. | |
| 22234149 |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo/Glimepiride | Patients treated with matching placebo (up to 18 weeks) followed by Glimepiride (after 18 weeks to 52 weeks) |
| FG001 | Linagliptin | Patients treated with Linagliptin 5mg once daily (up to 52 weeks) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Drug |
0 mg placebo comparator for part 1 of study (to 18 weeks) |
|
| Glimepiride | Drug | 1-4mg for part 2 of study (weeks 19-52) |
|
Odds ratios are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance. |
| Week 18 |
| Percentage of Patients With HbA1c<6.5 at Week 18 (Interim Analysis) | Odds ratios are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance. | Week 18 |
| Percentage of Patients With HbA1c Lowering by 0.5% at Week 18 (Interim Analysis) | Odds ratios are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance. | Week 18 |
| The Change in HbA1c From Baseline by Visit Over Time | HbA1c is measured as a percentage. Thus, this change from baseline reflects the HbA1c percent (at weeks 6, 12, 18, 22, 26, 30, 34, 40, 46, 52) minus the Week 0 HbA1c percent. | Baseline and weeks 6,12, 18, 22, 26, 30, 34, 40, 46, 52 |
| The Change in FPG From Baseline by Visit Over Time | This change from baseline reflects the FPG (at weeks 6, 12, 18, 22, 26, 30, 34, 40, 46, 52) minus the Week 0 FPG. | Baseline and weeks 6,12,18, 22, 26, 30, 34, 40, 46, 52 |
| Peoria |
| Arizona |
| United States |
| 1218.50.10013 Boehringer Ingelheim Investigational Site | Greenbrae | California | United States |
| 1218.50.10016 Boehringer Ingelheim Investigational Site | Harbor City | California | United States |
| 1218.50.10017 Boehringer Ingelheim Investigational Site | Huntington Park | California | United States |
| 1218.50.10006 Boehringer Ingelheim Investigational Site | Los Angeles | California | United States |
| 1218.50.10007 Boehringer Ingelheim Investigational Site | Miami | Florida | United States |
| 1218.50.10004 Boehringer Ingelheim Investigational Site | Statesville | North Carolina | United States |
| 1218.50.10002 Boehringer Ingelheim Investigational Site | Eugene | Oregon | United States |
| 1218.50.10015 Boehringer Ingelheim Investigational Site | Greer | South Carolina | United States |
| 1218.50.10005 Boehringer Ingelheim Investigational Site | Kingsport | Tennessee | United States |
| 1218.50.10012 Boehringer Ingelheim Investigational Site | Dallas | Texas | United States |
| 1218.50.10022 Boehringer Ingelheim Investigational Site | Dallas | Texas | United States |
| 1218.50.10010 Boehringer Ingelheim Investigational Site | San Antonio | Texas | United States |
| 1218.50.10018 Boehringer Ingelheim Investigational Site | San Antonio | Texas | United States |
| 1218.50.11001 Boehringer Ingelheim Investigational Site | Edmonton | Alberta | Canada |
| 1218.50.11003 Boehringer Ingelheim Investigational Site | Edmonton | Alberta | Canada |
| 1218.50.11005 Boehringer Ingelheim Investigational Site | Sarnia | Ontario | Canada |
| 1218.50.11002 Boehringer Ingelheim Investigational Site | Montague | Prince Edward Island | Canada |
| 1218.50.11004 Boehringer Ingelheim Investigational Site | Saskatoon | Saskatchewan | Canada |
| 1218.50.52007 Boehringer Ingelheim Investigational Site | Aguascalientes | Mexico |
| 1218.50.52010 Boehringer Ingelheim Investigational Site | Guadalajara | Mexico |
| 1218.50.52009 Boehringer Ingelheim Investigational Site | León | Mexico |
| 1218.50.52002 Boehringer Ingelheim Investigational Site | México | Mexico |
| 1218.50.52004 Boehringer Ingelheim Investigational Site | México | Mexico |
| 1218.50.52005 Boehringer Ingelheim Investigational Site | México | Mexico |
| 1218.50.52008 Boehringer Ingelheim Investigational Site | México | Mexico |
| 1218.50.52001 Boehringer Ingelheim Investigational Site | Monterrey | Mexico |
| 1218.50.52003 Boehringer Ingelheim Investigational Site | Monterrey | Mexico |
| 1218.50.63003 Boehringer Ingelheim Investigational Site | Cebu | Philippines |
| 1218.50.63005 Boehringer Ingelheim Investigational Site | Cebu | Philippines |
| 1218.50.63006 Boehringer Ingelheim Investigational Site | Manila | Philippines |
| 1218.50.63008 Boehringer Ingelheim Investigational Site | Manila | Philippines |
| 1218.50.63001 Boehringer Ingelheim Investigational Site | Marikina City | Philippines |
| 1218.50.63004 Boehringer Ingelheim Investigational Site | Marikina City | Philippines |
| 1218.50.63007 Boehringer Ingelheim Investigational Site | Pasay | Philippines |
| 1218.50.63002 Boehringer Ingelheim Investigational Site | Pasig | Philippines |
| 1218.50.63009 Boehringer Ingelheim Investigational Site | Pasig | Philippines |
| 1218.50.40004 Boehringer Ingelheim Investigational Site | Brasov | Romania |
| 1218.50.40001 Boehringer Ingelheim Investigational Site | Bucharest | Romania |
| 1218.50.40002 Boehringer Ingelheim Investigational Site | Bucharest | Romania |
| 1218.50.40005 Boehringer Ingelheim Investigational Site | Galati | Romania |
| 1218.50.40003 Boehringer Ingelheim Investigational Site | Sibiu | Romania |
| 1218.50.70001 Boehringer Ingelheim Investigational Site | Moscow | Russia |
| 1218.50.70003 Boehringer Ingelheim Investigational Site | Moscow | Russia |
| 1218.50.70002 Boehringer Ingelheim Investigational Site | Saint Petersburg | Russia |
| 1218.50.70004 Boehringer Ingelheim Investigational Site | Saint Petersburg | Russia |
| 1218.50.70005 Boehringer Ingelheim Investigational Site | Saint Petersburg | Russia |
| 1218.50.38002 Boehringer Ingelheim Investigational Site | Kharkiv | Ukraine |
| 1218.50.38001 Boehringer Ingelheim Investigational Site | Kiev | Ukraine |
| 1218.50.38004 Boehringer Ingelheim Investigational Site | Kiev | Ukraine |
| 1218.50.38003 Boehringer Ingelheim Investigational Site | Lviv | Ukraine |
| 1218.50.38005 Boehringer Ingelheim Investigational Site | Vinnitsa | Ukraine |
| Derived |
| Johansen OE, Neubacher D, von Eynatten M, Patel S, Woerle HJ. Cardiovascular safety with linagliptin in patients with type 2 diabetes mellitus: a pre-specified, prospective, and adjudicated meta-analysis of a phase 3 programme. Cardiovasc Diabetol. 2012 Jan 10;11:3. doi: 10.1186/1475-2840-11-3. |
| COMPLETED |
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| NOT COMPLETED |
|
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Number of participants and other baseline values taken from interim analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo/Glimepiride | Patients treated with matching placebo (up to 18 weeks) followed by Glimepiride (after 18 weeks to 52 weeks) |
| BG001 | Linagliptin | Patients treated with Linagliptin 5mg once daily (up to 52 weeks) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Body Mass Index (BMI) continuous | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||
| Glycosylated hemoglobin (HbA1c) - Interim Analysis | Baseline HbA1c was determined for the Full Analysis Set with a total of 73 patients treated with Placebo and 147 patients treated with Linagliptin (220 in total). | Mean | Standard Deviation | percent |
| ||||||||||||||
| Fasting blood plasma (FPG) glucose | Baseline fasting blood plasma glucose was determined for the Full Analysis Set with a total of 73 patients treated with Placebo and 147 patients treated with Linagliptin (220 in total). | Mean | Standard Deviation | mg/dL |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | HbA1c Change From Baseline at Week 18 (Interim Analysis) | HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance. | The Full Analysis Set (FAS) included all treated patients with a baseline and at least one on-treatment HbA1c measurement available during the first phase of the study. Last Observation Carried Forward (LOCF) was used as the imputation rule. | Posted | Mean | Standard Error | percent | Baseline and week 18 |
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| Primary | HbA1c Change From Baseline at Week 18 (Final Analysis) | HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance. HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance. The primary analysis was re-run at the completion of the study in the final study report. | The Full Analysis Set (FAS) included all treated patients with a baseline and at least one on-treatment HbA1c measurement available during the first phase of the study. Last observation carried forward (LOCF) was used as the imputation rule. | Posted | Mean | Standard Error | percent | Baseline and week 18 |
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| Secondary | Fasting Plasma Glucose (FPG) Change From Baseline at Week 18 (Interim Analysis) | This change from baseline reflects the Week 18 FPG minus the Week 0 FPG. Means are adjusted for baseline FPG, baseline HbA1c, prior OADs and reason for metformin intolerance (Interim Analysis). | All patients in FAS with values for FPG at baseline and at week 18. Last Observation Carried Forward (LOCF) was used as the imputation rule (Interim Analysis). | Posted | Mean | Standard Error | mg/dl | Baseline and week 18 |
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| Secondary | Percentage of Patients With HbA1c<7.0 at Week 18 (Interim Analysis) | Odds ratios are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance. | Full Analysis Set (FAS) patients with baseline HbA1c >= 7.0%. Patients without a value at week 18 were analysed as non-responders. | Posted | Number | percent of patients | Week 18 |
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| Secondary | Percentage of Patients With HbA1c<6.5 at Week 18 (Interim Analysis) | Odds ratios are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance. | FAS patients with baseline HbA1c >= 6.5%. Patients without a value at Week 18 were analysed as non-responders. | Posted | Number | percent of patients | Week 18 |
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| Secondary | Percentage of Patients With HbA1c Lowering by 0.5% at Week 18 (Interim Analysis) | Odds ratios are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance. | The Full Analysis Set (FAS) included all treated patients with a baseline and at least one on-treatment HbA1c measurement available during the first phase of the study. Patients without a value at week 18 were analysed as non-responders. | Posted | Number | percent of patients | Week 18 |
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| Secondary | The Change in HbA1c From Baseline by Visit Over Time | HbA1c is measured as a percentage. Thus, this change from baseline reflects the HbA1c percent (at weeks 6, 12, 18, 22, 26, 30, 34, 40, 46, 52) minus the Week 0 HbA1c percent. | Treated set (OC) | Posted | Mean | Standard Deviation | percent | Baseline and weeks 6,12, 18, 22, 26, 30, 34, 40, 46, 52 |
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| Secondary | The Change in FPG From Baseline by Visit Over Time | This change from baseline reflects the FPG (at weeks 6, 12, 18, 22, 26, 30, 34, 40, 46, 52) minus the Week 0 FPG. | Treated set (OC) | Posted | Mean | Standard Deviation | mg/dL | Baseline and weeks 6,12,18, 22, 26, 30, 34, 40, 46, 52 |
|
|
52 weeks + 7 days
These are the total results after the final completion of the study after 52 weeks. The time frame 52 weeks + 7 days (post-trt) is the maximum time frame. Some patients were not followed up for this long, and will correspondingly have had less opportunity to report the events.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo/Glimepiride | Patients treated with matching placebo (up to 18 weeks) followed by Glimepiride (after 18 weeks to 52 weeks) | 3 | 76 | 40 | 76 | ||
| EG001 | Linagliptin | Patients treated with Linagliptin 5mg once daily (up to 52 weeks) | 1 | 151 | 59 | 151 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
|
Primary analysis (at interim) was rerun using final study database
Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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Not provided
| ID | Term |
|---|---|
| D000069476 | Linagliptin |
| C057619 | glimepiride |
| ID | Term |
|---|---|
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011799 | Quinazolines |
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